Colorectal cancer (CRC) is one of the most common cancers accounting for approximately 10% of all cancer cases and approximately 8% of all cancer deaths. Solid cancers are normally diagnosed based on a histo pathological tissue evaluation, where the gold standard for CRC is fiber-optic colonoscopy. This technology is labor intensive, time consuming, costly and extremely invasive. The alternative of fecal occult blood test (FOBT), while not as invasive, is known to suffer from low sensitivity.
Screening and monitoring assays are essential for early detection and management of cancer. Blood-based tests enable large-scale screening of clinically asymptomatic (supposedly healthy) individuals, for diagnosis, monitoring and prediction of cancer. Furthermore, blood-based sampling is prevalent and convenient, and therefore may increase compliance in asymptomatic populations.
Bonilla et al. (Oncology Letters, 2, 719-714, 2011) disclose mRNA biomarkers associated with poor outcome in patients suffering from advanced stages of colorectal cancer.
Comprehensive lists of hundreds of genes that may be associated with colorectal cancer were disclosed, for example, in Ye et al., Plos one, 2013; 8 (5), e62870; and Garcia et al., Clinical Chem. 53 (10): 1860-1863, 2007. Marshall et al. (Int J Cancer 2010; 126: 1177-1186) disclose a biomarker for CRC based on RNA extracted from peripheral blood cells corresponding to a panel of seven genes: ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6, VNN1 and IL2RB.
US 2010/0330079 discloses a method for the detection of protein biomarkers for early diagnosis and management of colorectal cancer. The method includes obtaining quantitative information about the expression of 51 genes in peripheral blood.
WO 2011/012136 discloses a method for discriminating between CRC and non-cancerous samples based on the expression level of a group of miRNAs.
There is an unmet need for cost-effective, rapid, accurate and minimally invasive methods and kits for early detection and treatment of pre-cancerous advanced polyps and colorectal cancer, with improved sensitivity and specificity.